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NCT00042458 Clinical Trial

Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00042458
Other study ID # 137-150
Secondary ID
Status Completed
Phase Phase 3
First received July 30, 2002
Last updated September 22, 2015
Start date April 2002
Est. completion date March 2003

Study information
Verified date August 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.

Recruitment information / eligibility
Status Completed
Enrollment 296
Est. completion date March 2003
Est. primary completion date March 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- HbA1c value between 7.5-9%

- Using multiple daily insulin injections

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pramlintide acetate
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
• Placebo
The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.

Locations
Country Name City State
United States Atlanta Diabetes Associates Atlanta Georgia
United States Medical Research Unlimited Aventura Florida
United States Medical Research Unlimited Aventura Florida
United States University of Maryland Joslin Diabetes Center Baltimore Maryland
United States Mercury Street Medical Butte Montana
United States Physicians for Clinical Research Camp Hill Pennsylvania
United States St. James Diabetes Center Chicago Heights Illinois
United States St. James Diabetes Center Chicago Heights Illinois
United States Ohio State Univ.-Division of Endocrinology, Diabetes Columbus Ohio
United States East Bay Clinical Trial Center Concord California
United States Barbara Davis Center for Childhood Diabetes Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States UNC Diabetes Care Center Durham North Carolina
United States Internal Medicine Associates Fort Myers Florida
United States Valley Research Fresno California
United States Grand Rapids Associated Interns Grand Rapids Michigan
United States Indiana University Outpatient Clinical Research Indianapolis Indiana
United States North Texas Clinical Research Irving Texas
United States Private Practice Lufkin Texas
United States Private Practice Lufkin Texas
United States Ana Ventures LLC Mesa Arizona
United States Vanderbilt University Medical Center Nashville Tennessee
United States Suncoast Clinical Research New Port Richey Florida
United States Phoenix Endocrinology Clinic, Ltd. Phoenix Arizona
United States Radiant Research Portland Oregon
United States Rainier Clinical Research Center Renton Washington
United States UCSD Diabetes Research Center San Diego California
United States Diabetes Research Institute San Mateo California
United States Sansum Medical Research Institute Santa Barbara California
United States Radiant Research St. Louis Missouri
United States Children's Clinic Tallahassee Florida
United States Diablo Clinical Research Walnut Creek California
United States MedStar Clinical Research Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary - To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes. 29 Weeks
Secondary - To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study. 29 Weeks
Secondary - To examine the pattern of daily insulin use over the course of the study. 29 Weeks
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